(1) Technical Field of the Invention
This invention relates to mammaplasty augmentation and more particularly, to a method of accurately sizing a breast prosthesis prior to implantation and to a method of implanting an accurately sized breast prosthesis.
(2) Description of the Prior Art
It is well known in the field of plastic surgery that a human breast may be augmented or enlarged, either for medical or cosmetic reasons, with prosthetic implants. In one common surgical procedure, an incision is made through the skin along the bottom of the patient's breast, the breast tissue is elevated, and a pocket or cavity is formed between the breast tissue and the underlying chest wall. If the breast tissue or mammary glands have been previously removed during a mastectomy, then the cavity is present between the patient's skin and chest wall. The surgeon has a set of premanufactured, sterilizable implants sized and marked in volumes from 125 cc to 325 cc in 25 cc increments. The surgeon selects one of the sterilizable implants, inserts it into place through the incision, and determines by visual and manual inspection if the implant is of the proper or desirable size. If not, the surgeon removes the implant, selects a second implant of another size, inserts the second implant into place, and again determines if the implant is of the proper size. This procedure is repeated until the surgeon has, by trial and error, determined the necessary size for the implant. Then the sterilizable implant is removed, a final premanufactured implant, sized by the above method, is inserted in place and the incision is closed by suturing or the like. The final implant is typically an elastomeric silicone bag containing a saline solution or a silicone gel.
This procedure has the disadvantage that the determination of the final implant size is basically a trial and error procedure and requires that an implant be inserted into the patient and then removed several times or more before the final implant is inserted in place. Such a procedure is lengthy to perform and may cause additional damage to the patient due to the repeated insertion and removal of the sterilizable implants.
U.S. Pat. No. 4,024,856 discloses a method and apparatus for measuring the size of a breast relative to a predetermined volume and for determining the difference in size between a woman's right breast and left breast. A template of predetermined size and shape, larger than the patient's breast, is placed over each breast and a measured amount of fluid is injected between the template and the breast. By measuring the differences between the known volume of the template and the known volume of liquid injected, the breast size may be determined and an implant sized accordingly. However, this apparatus and method is quite cumbersome and messy and requires the construction of a template corresponding to the desired final size and shape of the breast. In addition the final appearance of the patient's breast will be known only after a breast implant is finally inserted.
It is also known in the art to implant an empty elastomeric silicone balloon in a patient's breast, inflate the balloon through a filler tube with a saline solution or similar liquid until the desired size is reached, and then seal off the opening to the now implanted and filled balloon. Such devices and methods are disclosed, for example, in U.S. Pat. Nos. 4,143,428; 4,095,295; 3,600,718; and 3,416,160. Once the balloon is filled it must be sealed by plugging or otherwise closing off the filler tube. Such an implant is not as reliable as a permanently sealed implant and leaks or other problems may arise after the surgery is completed.
Accordingly, it is an object of the present invention to accurately determine the size of a desired breast implant without a repeated trial and error procedure and, thereby, enable a final implant to be inserted without the necessity of sealing the final implant.